Cleared Traditional

K170819 - AcQMap 3D Imaging and Mapping Catheter

K170819 is an FDA 510(k) clearance for AcQMap 3D Imaging and Mapping Catheter, manufactured by Acutus Medical, Inc.. The device is a Class 2 Cardiovascular device with product code MTD cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K170819 · Acutus Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
210d
Days
Class 2
Risk

K170819 is an FDA 510(k) clearance for the AcQMap 3D Imaging and Mapping Catheter. Classified as Catheter, Intracardiac Mapping, High-density Array (product code MTD), Class II - Special Controls.

Submitted by Acutus Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on October 16, 2017 after a review of 210 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Acutus Medical, Inc. devices

FDA 510(k) Submission Details - K170819

510(k) Number K170819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2017
Decision Date October 16, 2017
Days to Decision 210 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence.

MTD Device Classification - Class 2, Special Controls

Product Code MTD Catheter, Intracardiac Mapping, High-density Array
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Cardiovascular devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02469649 Completed Interventional Industry-sponsored

Dipole Density Mapping in Supraventricular Tachycardia

Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia

85
Patients (actual)
8
Sites
Diagnostic
Purpose
Open label
Masking
Condition studied Supraventricular Tachycardia
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Petr Neuzil, MD
Sponsor Acutus Medical (industry)
Started 2014-09-06 → Primary completion 2017-05-22
Primary outcome
Number of Participants With Freedom From Device-and Procedure-related Adverse Events and Serious Adverse Events
View full study on ClinicalTrials.gov

Regulatory Peers - MTD Catheter, Intracardiac Mapping, High-density Array

All 25
Devices cleared under the same product code (MTD) and FDA review panel - the closest regulatory comparables to K170819.
Pentaray Nav eco High-Density Mapping Catheter
K201750 · Biosense Webster, Inc. · Aug 2020
Carto Octaray Mapping Catheter with Trueref Technology
K193237 · Biosense Webster, Inc. · Jul 2020
Advisor HD Grid Mapping Catheter, Sensor Enabled
K172393 · St. Jude Medical, Inc. · Apr 2018
CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER
K140733 · Boston Scientific Corporation · Apr 2014
PENTARAY NAV ECO HIGH-DENSITY MAPPING CATHETER
K123837 · Biosense Webster, Inc. · Mar 2013
PENTARAY NAV HIGH-DENSITY MAPPING CATHETER
K120425 · Biosense Webster, Inc. · May 2012